The protocol prepared according to local requirements and international guidelines to collect the real world evidence data in the best possible way.

Data collection form (CRF) designed in compliance with the protocol and study purpose, informed consent form designed according to up-to-date guidelines.

The application file for Ethics Committee Dossier and the Ministry of Health Turkey Pharmaceuticals and Medical Devices Agency is prepared due to procedures and the process is carried up by Omega CRO.

Monitorization services are carried out accordance with the study protocol and the data is gathered at the centre. Then the compliance of the data with GCP guidelines is checked. Apart from monitoriziation, information updates are done by contacting with the centers.

 To increase speed/quality of data collection process, site data entry support personnel assist the researchers in the data entry process. 

Data management in observational trials is important (but not as rigid as in clinical trials) for the quality of the work. Queries generated by the experienced Omega CRO data management team boosts the quality of observational trials.

Data entry is carried out simultaneously with observational trials, so it is easy to advance to analysis stage at the end of the study. With an experienced data entry team fast and reliable data entry process is completed.

Omega CRO with an experienced statistics team, analysis of data collected through observational trials are conducted in accordance with the purpose of the study.

Final study reports, abstracts, posters and writing medical paper is done by an experienced medical writing team of Omega CRO.